The trials were conducted at private clinics by doctors of the mental hospital attached to the Mahatma Gandhi Medical College, Indore, between January 2008 and October 2010. This came to light following Madhya Pradesh chief minister Shivraj Singh Chouhan’s answer to a question raised in the assembly.
The question was raised in July this year but the reply given then was incomplete. The chief minister’s detailed reply came during the assembly’s winter session that ended on December 3.
Significantly, the doctors involved had taken the approval for the trials from independent ethics committees attached to private hospitals both within and outside the state, thus bypassing the Mahatma Gandhi Medical College’s own institutional ethics committee.
Chouhan’s reply, tabled in the assembly, mentioned the names of five mental hospital doctors involved in the trials – Ramgulam Rajdan, V S Pal, Ujwal Sardesai, Abhay Paliwal and Pali Rastogi. It also came to light that the clinics where the trials were conducted did not have the mandatory registration certificate from the district chief medical and health officer.
MP’s chief medical and health officer, Dr Sharad Pandit, told TOI that his office had registered a few clinics on the recommendation of the MG Medical College dean. However, two doctors mentioned in the CM’s reply claimed they had done no wrong. "We did the trial in private clinics, so we took the approval from independent ethics committees," said Dr V S Pal. Asked why the MG Medical College’s own institutional ethics committee was bypassed, he refused comment.
Dr Abhay Paliwal, another doctor named, said, "We are allowed to conduct clinical trials at private clinics. We have followed all DCGI and ICMR norms." According to him, it was not necessary to go to the medical college’s ethics committee as the trials were conducted at private clinics.
Interestingly, the Indian Council for Medical Research (ICMR) guidelines say that independent ethics committees are for those who work in institutes that do not have their own institutional ethics committees.
Dr Anand Rai, a whistle-blower and health activist, speaking to TOI, alleged that these doctors took the approval from independent ethics committees to avoid disclosure of information under RTI.